FDA 483 - BrittonField Laboratories Inc. - July 08, 2022

An FDA inspection of BrittonField Laboratories Inc., a contract testing laboratory in East Syracuse, NY, revealed two significant observations. The firm failed to establish the accuracy, sensitivity, specificity, and reproducibility of test methods, including a lack of method transfer studies for several analytical procedures. Additionally, the inspection found that the firm had not established written procedures for equipment cleaning and maintenance, nor completed cleaning validation studies for equipment used in drug product manufacturing.